Regulatory Focus™ > News Articles > Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

Posted 16 April 2012 | By Alexander Gaffney, RAC 

Comments on the US Food and Drug Administration's (FDA) February 2012 draft guidance documents on biosimilar are mostly negative and reflecting discontent with the required studies to prove biosimilarity, reports Genetic Engineering & Biotechnology News (GEN).

In comments submitted to the Federal Register during FDA's comment period, several large biopharmaceutical manufacturers and patient organizations expressed their views on the trio of guidelines, which were issued as a result of the passage of the Biosimilar Price Competition and Innovation Act (BPCI).

In particular, manufacturer Genentech said FDA's use of regulatory verbiage suggesting biosimilar manufacturers "should" conduct biosimilarity assessments between their products and the innovative biologic product was missing how "fundamental" these tests are to proving biosimilarity.

"Please replace 'should' with 'is expected to' or 'needs to,'" said Genentech in a statement.

Novo Nordisk, too, urged FDA to tighten their standards on what constituted biosimilarity, and asked FDA to require "at least one comparative clinical pharmacokinetic study" and comparative clinical immunogenicity and comparative clinical pharmacokinetic studies, where appropriate.

Patient groups, too, pressed FDA for greater safety assurances, reports GEN.

The Colon Cancer Alliance and the Global Healthy Living Foundation both asked for strong testing requirements, asking that they be "extensive" and "robust," respectively.

Read more:

GEN - Comments Sent to FDA on Its Draft Biosimilars Guidance Mostly Conveyed Discontent

Regulatory Focus - FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act

Regulatory Focus - FDA Seeks Input on Biosimilars Application

Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 

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